New

Senior Manager, Manufacturing

Sarepta Therapeutics
United States, Massachusetts, Burlington
Jan 11, 2025
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us The Importance of the Role This position will report to the Director, Gene Therapy Manufacturing and will be responsible for oversight of all aspects of manufacturing (make, assess and release) at the CMO to ensure clinical and commercial drug supply needs are met The Opportunity to Make a Difference Participating inthecross-functionalworkingteam to support GMP (upstream and downstream) production at CMO partners Building business processes and cross-functional relationships with internal/external partners.This includes applicable metrics and program- tracking. Ensuring that all contractual obligations with our CMOs are metto Sarepta Quality standards, includingon-time manufacturing, QC testing, QMS record closureand batch disposition. Authoring and/ or review ofQuality System documentation, including technical reports,deviationsand change controls. Provide manufacturing technical expertisein meetings related to QMS documentation. Provide front-line support for process or equipment related issues at the CMO and ensure cross-functional engagement internally.This includes person-in plant (PIP) responsibilities. Lead or drive the resolution of major and critical deviation investigations. Partner with Process Development and Quality for tech transfer as well as to qualify and validate the manufacturing processesand QC methods. Technical review ofSOPs, batch records and supporting documentation as needed. More about You Degree in Engineering or Life Sciences,with 8+ yearsof relevant industry experience. Strongworking knowledge of FDA regulations (GMPs) and industry standards. Experience with Gene Therapy or biologics BDS production or development preferred. Strong project management and organizational skills. Excellent communication skills and ability to influence across multiple functions. 20% travel anticipated. What Now? We're always looking for solution-oriented, critical thinkers. So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid #LI-TR1 This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $112,000 - $140,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.